Anesthesia Intubation Complication Clinical Trial
Official title:
Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide Diffusion Under General Anesthesia
When using nitrous oxide for general anesthesia, nitrous oxide diffusion induces intracuff
hyperinflation of the endotracheal tube. Furthermore the difference among various types of
cuffed endotracheal tubes in cuff pressure behavior during nitrous oxide exposure.
TaperGuard(TM) tube has been newly introduced and has tapered-shape cuff. In vitro study,
the intracuff pressure of TaperGuard(TM) tube was lower than that of conventional tube with
cylindrical-shaped cuff of the conventional tube(Hi-Lo(TM) tube). Therefore, this clinical
study is needed to evaluate the intracuff pressure during general anesthesia with nitrous
oxide exposure.
Status | Completed |
Enrollment | 38 |
Est. completion date | April 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients who will undergo general anesthesia in a supine position with a neutral position of the head (hand and forearm sugery) - 18~70 years old - American society of anesthesiologists physical status 1-2 - Body mass index < 30 kg/m2 Exclusion Criteria: - Contraindication for nitrous oxide - Difficult intubation - Cormack-Lehane grade > 3 - Airway-related or pulmonary diseases - Short or long operation time (< 1 hour or > 3 hours) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Dongguk University Ilsan Hospital | Goyang | Gyeonggido |
Lead Sponsor | Collaborator |
---|---|
DongGuk University |
Korea, Republic of,
Tsuboi S, Miyashita T, Yamaguchi Y, Yamamoto Y, Sakamaki K, Goto T. The TaperGuard™ endotracheal tube intracuff pressure increase is less than that of the Hi-Lo™ tube during nitrous oxide exposure: a model trachea study. Anesth Analg. 2013 Mar;116(3):609-12. doi: 10.1213/ANE.0b013e318279b399. Epub 2013 Feb 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intracuff pressure of the endotracheal tube after 60 min (1 hour) with exposure to nitrous oxide | One hour after the exposure to nitrous oxide under general anesthesia | No | |
Secondary | Intracuff pressure of the endotracheal tubes | Intracuff pressures will be measured with a manometer (VBM, Sulz, Germany) | 0, 10, 20, 30, 40, 50 minutes after exposure to nitrous oxide | No |
Secondary | Postoperative sore throat: incidence | About 1, 6, 24 hours after termination of anesthesia | No | |
Secondary | Postoperative hoarseness: incidence | About 1, 6, 24 hours after termination of anesthesia | No | |
Secondary | Postoperative dysphagia: incidence | About 1, 6, 24 hours after termination of anesthesia | No |
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